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TAURAZIL SR 5 MG TABLETS

Active substance(s): ALFUZOSIN HYDROCHLORIDE

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Package Leaflet: Information for the patient
Taurazil SR 5 mg Tablets
alfuzosin hydrochloride
For Male Adults

Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It
may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.

1.
2.
3.
4.
5.
6.

What is in this leaflet:
What Taurazil SR is and what it is used for
What you need to know before you take Taurazil SR
How to take Taurazil SR
Possible side effects
How to store Taurazil SR
Contents of the pack and other information

1.

What Taurazil SR is and what it is used for

Taurazil SR contains the active ingredient alfuzosin, which belongs to a group of
medicines called alpha-adrenoreceptor antagonists or alpha-blockers.
It is used to treat moderate to severe symptoms caused by an enlarged prostate gland,
a condition that is also called benign (non-cancerous) prostatic hyperplasia. The
prostate gland lies underneath the bladder. It surrounds the urethra, the tube that takes
your urine to the outside of the body. If the prostate gets bigger, it presses on the
urethra making it smaller. Enlarged prostate glands can cause urinary problems such
as frequent and difficult urination, especially at night. Alpha-blockers relax the
muscles in the prostate and bladder neck. This allows urine to flow out of the bladder
more easily.

2.



What you need to know before you take Taur azil SR

Do not take Taurazil SR if you:
are allergic to alfuzosin, other quinazoline medicines (e.g. terazosin, doxazosin) or to
any of the other ingredients of this medicine (listed in section 6).
suffer from conditions that cause a marked drop in blood pressure when standing up
(your doctor may have told you this is called ‘postural’ or ‘orthostatic’ hypotension).
This can make you feel dizzy.




have liver problems.
take other medicines that belong to the group known as alpha-blockers (see below
section on ‘Other medicines and Taurazil SR’).

Warnings and precautions








Talk to your doctor or pharmacist before taking Taurazil SR if you:
have severe kidney problems
take medicines to treat high blood pressure. In this case your doctor will check your
blood pressure regularly, especially at the beginning of treatment.
have experienced a marked drop in blood pressure in the past after taking another
medicine belonging to the group of known as alpha-blockers. In this case your doctor
will start treatment with alfuzosin at low doses and will gradually increase the dose.
suffer from acute heart failure (a weakness of the heart muscle), or other heart
problems.
have, or have had, problems with decreased blood flow to parts of the brain (cerebral
circulatory disturbances
suffer from chest pain (angina) and are treated with a nitrate. Use of nitrates and
alfuzosin at the same time may increase the risk of decreasing blood pressure. Your
doctor may stop treating you with alfuzosin if your angina comes back or worsens.
were born with, or have had any condition associated with an abnormal heart rhythm
(which may be seen on ECG test which looks at the electrical activity of the heart) or
you take medicines known to affect the heart rhythm.
During treatment
When taking this medicine, you may experience a sudden drop in blood pressure
when you stand up (you may feel dizzy, tired, weak or sweaty), particularly in the first
few hours after taking. If this happens, you should lie down with your legs and feet up
in the air until the symptoms have disappeared. Usually, these effects last for only a
short time and occur at the start of the treatment. Normally, there is no need to stop
treatment.
If you need to have eye surgery because of cataract (cloudiness of the lens) please
inform your eye specialist before the operation that you are taking or have previously
taken alfuzosin. This is because alfuzosin may cause complications during the
surgery, which can be managed if your specialist is prepared in advance.
Children and adolescents
Alfuzosin is not recommended for use in children and adolescents (patients below 16
years of age).
Other medicines and Taurazil SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines, including medicines obtained without a prescription.
Do not take Taurazil SR if you are taking other medicines that belong to the group
known as alpha-blockers, such as doxazosin, indoramin, terazosin, prazosin or
tamsulosin.

-

Taurazil SR and some medicines may interfere with each other. Talk to your doctor or
pharmacist if you are taking any of the following:
ketoconazole and itraconazole (medicines used to treat fungal infections)
medicines used to treat HIV (such as ritonavir).
clarithromycin and telithromycin (medicines to treat bacterial infections).

- nefazodone (a medicine used for depression).
- medicines to lower blood pressure.
- medicines (nitrates) used to treat the symptoms of chest pain (angina).
- medicines normally used to treat impotence (erectile dysfunction).
The concomitant use of Taurazil SR at the same time as medicines used to treat high
blood pressure, nitrates used to treat heart problems such as chest pain (angina) or to treat
impotence may lead to low blood pressure.
If you are going to have an operation that needs a general anaesthetic, tell your doctor
or hospital staff that you are taking this medicine. Your doctor may recommend that
you stop taking this medicine 24 hours before the operation, to help prevent the risk of
blood pressure changes.
Pregnancy and breast-feeding
Taurazil SR should only be used by men.

Driving and using machines
Especially at the beginning of treatment with Taurazil SR you may feel lightheaded,
dizzy or weak. Do not drive or operate machinery or perform any hazardous tasks
until you know how your body responds to the treatment.
Taurazil SR contains lactose
If you have been told by your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicine.

3.

How to take Taurazil SR

Always take this medicine exactly as your doctor or pharmacist has told you. Check
with your doctor or pharmacist if you are not sure.
The recommended dose is one tablet (5 mg alfuzosin) twice daily (in the morning and
in the evening).
Do not take more than 2 tablets per day. Take the first tablet at bedtime.
Swallow the tablets whole with a sufficient amount of fluid with or without food. Do
not crush, powder, divide or chew the tablets as too much of the active substance
alfuzosin may reach your body too quickly. This may increase the risk of unwanted
side effects.
If you have kidney problems or are elderly
If you have mild to moderate kidney problems or are elderly, the recommended dose
is one tablet (5 mg alfuzosin) once daily. Your doctor may recommend that you
increase the dose to one tablet (5 mg alfuzosin) twice daily depending on how you
respond to the treatment. Take the first tablet at bedtime.

If you take more Taurazil SR than you should
If you take large amounts of Taurazil SR your blood pressure may suddenly drop and
you may feel dizzy or even faint. If you begin to feel dizzy, sit or lie down until you
feel better. If the symptoms do not disappear, call your doctor as the drop in blood
pressure may have to be treated in hospital.
If you forget to take Taurazil SR
Do not take a double dose to make up for a forgotten tablet as this may cause a sudden
drop in blood pressure. Take the next tablet as directed.
If you stop taking Taurazil SR
You should not interrupt or stop taking Taurazil SR without speaking to your doctor
first.
If you want to stop the treatment or have any further questions on the use of this
medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
If you notice any of the following side effects, stop taking this medicine and
contact your doctor or go to the nearest hospital casualty department straight
away:

worsening of, or new onset of, chest pain (angina). Normally, this only
happens if you have had angina before.

red and lumpy skin rash (hives), swelling of the eyelids, face, lips, mouth or
tongue, difficulty in breathing or swallowing. These are symptoms of serious allergic
reactions.

an increase in the number of infections (e.g. sore throat, mouth ulcers etc. and
fever) that you may get. This may be a sign of a reduction in the number of white
blood cells.

an unusual or abnormal heart rhythm – you may notice a very fast or irregular
heartbeat, which may make you feel short of breath, dizzy or faint.

liver problems, which may be due to a blockage in the bile duct. You may feel
sick, notice a loss of appetite, pale stools, dark urine or yellowing of the skin and
whites of the eyes.

sudden collapse, numbness or weakness in the arms or leg, dizziness and
confusion, disturbances in vision, difficulty swallowing, slurred or loss of speech
(these may be signs of a stroke, or mini stroke caused by changes in blood supply to
parts of the brain). These is more likely in patients who have had previous problems
with blood flow to the brain.
Other possible side effects
Common (may affect up to 1 in 10 people):
Tiredness, dizziness, headache, faintness, a spinning sensation in the head (vertigo),
marked drop in blood pressure when standing up (especially when starting treatment
with too high a dose or when treatment is resumed), stomach pain, feeling sick
(nausea), diarrhoea, dry mouth, feeling of general weakness, generally feeling unwell.
Uncommon (may affect up to 1 in 100 people):
Feeling drowsy, vision/eye problems, faster heartbeat, fainting (especially when
starting treatment with too high a dose or when treatment is resumed), sensation of
pounding or racing heartbeat, runny nose, skin rash, itching, urinary incontinence,
water retention (e.g. swelling of ankles and feet), reddening of the face or body
(flushing/hot flushes), indigestion.

Not known (frequency cannot be estimated from available data):
Painful or prolonged erection (priapism), being sick (vomiting), unexplained bruising
or bleeding (this may be a sign of reduced number of platelets in the blood, which
help the blood to clot), sweating.

If you are having an operation on your eyes because of cataracts (where the lens of the
eye is cloudy) and are already taking or have taken alfuzosin in the past, the pupil
may dilate poorly and the iris (the coloured part of the eye) may become floppy
during the procedure. This only happens during the operation and it is important for
the eye specialist to be aware of this as the operation may need to be carried out
differently (see ‘Warnings and precautions’).
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How to store Taurazil SR

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton
after ‘EXP’. The expiry date refers to the last day of that month.
Do not throw away medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will
help protect the environment.

6.

Contents of the pack and other information

What Taurazil SR contains:
The active substance is alfuzosin hydrochloride. One prolonged-release tablet
contains 5 mg alfuzosin hydrochloride.
The other ingredients are lactose monohydrate, hypromellose, povidone, magnesium
stearate.

What Taurazil SR looks like and contents of the pack:
Taurazil SR 5 mg are white, round, bevelled-edged, uncoated tablets.
They are available in blister packs with 20, 28, 30, 50, 56, 60, 60 x l, 90, 100, 180 and
500 tablets.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer
Gerard Laboratories
35/36 Baldoyle Industrial Estate, Grange Road
Dublin 13
Ireland

This leaflet was last revised in: September 2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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